Skip to Content

Pharmaceutical News and Articles

Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Jan. 23, 2018

Posted yesterday in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Unclear if Heat-Not-Burn Tobacco Device Poses Fewer Health Risks Than Cigarettes: FDA It's not clear whether lower levels of some harmful chemicals produced by a device that heats tobacco without burning it would mean fewer health risks for users, compared with traditional cigarettes, a U.S. Food and Drug...

Read more

Tobacco's Harms May Come Sooner Than Smokers Think

Posted today in Medical

TUESDAY, Jan. 23, 2018 -- Smokers often think their habit won't have health consequences until far into the future, a small survey suggests. Researchers found that compared with nonsmokers, those who smoke generally believe that any health problems -- from yellow teeth to lung cancer -- would strike later in life. It's a perception, researchers said, that might delay some people's efforts to quit. Smoking rates in...

Read more

How to Sit Less, Move More

Posted today in Medical

TUESDAY, Jan. 23, 2018 -- Even if you're parked in front of a computer during the day, new research suggests that some simple changes can offset the health damage of all that sitting. "Even if we exercise regularly, most of us sit or recline for an average of 11 hours a day," said researcher Wuyou Sui, a doctoral student in the department of kinesiology at the University of Western Ontario. "Our bodies just aren't...

Read more

Lack of Vitamin D Can Sideline College Football Players

Posted today in Medical

TUESDAY, Jan. 23, 2018 -- Nearly 60 percent of college football players have low levels of vitamin D, a new study suggests. That means they face a significantly higher risk for muscle strain and injury, the researchers said. "We were interested in vitamin D in this population because it's been shown to play an important role in muscle function and strength, which is critical to the high-performance athlete," said...

Read more

Essure Female Sterilization Device Appears Safe: Study

Posted today in Medical

TUESDAY, Jan. 23, 2018 -- Essure implants used in female sterilization have come under fire in recent years, with women reporting a wide array of problems to the U.S. Food and Drug Administration. A new study from France shows the implants are relatively safe and do not raise the risk of side effects or health problems, however. The results show that Essure should remain on the market as a viable option for some...

Read more

Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot

Posted 2 days ago in New Drug Applications

Princeton, N.J.—January 21, 2018 — Braeburn Pharmaceuticals, Inc. (Braeburn) today announced that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the new drug application (NDA) for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). The FDA has requested additional inf...

Read more

Avion Pharmaceuticals Announces FDA Approval of Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) Oral Contraceptive

Posted 7 days ago in New Drug Approvals

ATLANTA, Jan. 17, 2018 /PRNewswire/ -- Avion Pharmaceuticals, LLC, the makers of the Prenate® line of prescription prenatal vitamins, received approval of its new drug application (NDA) for the oral contraceptive Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets), the company's first internally developed NDA. Avion expects to commercially launch this new oral contraceptive to ...

Read more

FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC

Posted 8 days ago in New Drug Approvals

Ridgefield, Conn., January 16, 2018 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. The n...

Read more

FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer

Posted 11 days ago in New Drug Approvals

January 12, 2018 -- The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug...

Read more

GSK Receives FDA Approval for Expanded Indication for Fluarix Quadrivalent (Influenza Vaccine) for Persons 6 Months and Older

Posted 13 days ago in New Drug Approvals

Philadelphia, PA, January 11, 2018 -- GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research expanding the indication for Fluarix Quadrivalent (Influenza Vaccine) to include use in persons 6 months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and t...

Read more

Lipocine Announces Outcome of FDA Advisory Committee Meeting for Tlando, Testosterone Replacement Therapy in Adult Males with Hypogonadism

Posted 13 days ago in New Drug Applications

SALT LAKE CITY, Utah, Jan. 10, 2018 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced that the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") voted six in favor and thirteen against the benefit/risk profile of Tlando, the Company's oral testosterone product candidate for testosterone replacement...

Read more

Ionis' Inotersen NDA Accepted for Priority Review by the FDA

Posted 2 weeks ago in New Drug Applications

CARLSBAD, Calif., Jan. 8, 2018 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that its New Drug Application (NDA) for inotersen has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA). Inotersen is an investigational drug for the treatment of patients with hereditary TTR amyloidosis (hATTR). Priority Review is granted by the FDA to drugs with the potential to...

Read more

FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection

Posted 2 weeks ago in New Drug Applications

KENILWORTH, N.J.--(BUSINESS WIRE)-- January 8, 2018 Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults. The NDAs include data for d...

Read more

Kala Pharmaceuticals Announces New Drug Application for Inveltys (KPI-121 1%) Has Been Accepted for Review by the U.S. Food and Drug Administration

Posted 2 weeks ago in New Drug Applications

WALTHAM, Mass.--(BUSINESS WIRE)--Jan. 5, 2018-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of product candidates using its proprietary mucus-penetrating particle (MPP) technology, today announced that the New Drug Application (NDA) for Inveltys (KPI-121 1%), a topical twice-a-day product candidate for the treatment of inflammation and pain...

Read more

FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma

Posted 2 weeks ago in New Drug Approvals

THOUSAND OAKS, Calif., Jan. 5, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The...

Read more

Monthly News Roundup - December 2017

Posted 3 weeks ago in Pharma Industry News

Luxturna Gene Therapy OK’d for Rare Form of Vision Loss A historic approval, Luxturna (voretigene neparvovec-rzyl) from Spark Therapeutics is the first directly administered gene therapy that targets a disease caused by specific gene mutations. In December the U.S. Food and Drug Administration (FDA) approved Luxturna, used in patients with biallelic RPE65-mediated inherited retinal disease (IRD), a form of v...

Read more

FDA Permits Marketing of Device to Treat Diabetic Foot Ulcers

Posted 3 weeks ago in Pharma Industry News

Today, the Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the...

Read more

FDA Clears Stereotactic Radiotherapy System for Use in Treating Breast Cancer

Posted 4 weeks ago in Pharma Industry News

December 22, 2017 -- Today, the U.S. Food and Drug Administration cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. “With today’s clearance, patients will have access to a treatment option that provides greater accuracy in delivering radiation therapy to breast tumors while saving surrounding breast tissue,” said Robert Ochs, Ph.D., acting deputy direc...

Read more

FDA Proposes New, Risk-Based Enforcement Priorities to Protect Consumers from Potentially Harmful, Unproven Homeopathic Drugs

Posted 5 weeks ago in Pharma Industry News

Today, the Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to o...

Read more

FDA Launches New Tool for Sharing Information That Allows Doctors to Better Manage Antibiotic Use

Posted 5 weeks ago in Pharma Industry News

Today the Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. This approach is...

Read more

Tenax Therapeutics Announces Plan to Develop Levosimendan for a Pulmonary Hypertension Indication with No FDA Approved Therapies

Posted 8 days ago in Clinical Trials

January 16, 2018 -- Tenax Therapeutics, Inc. (NASDAQ: TENX) today announced plans to advance the development of levosimendan for the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). PH-HFpEF is a common condition with a poor outcome (5 year survival less than 50%). Given that no therapies are approved to treat an estimated 1.5 million patients who suffer...

Read more

Syndax Pharmaceuticals Announces Clinical Collaboration to Evaluate Entinostat in Combination with anti-PD-L1 Cancer Immunotherapy in Breast Cancer

Posted 2 weeks ago in Clinical Trials

WALTHAM, Mass., Jan. 10, 2018 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, today announced a new clinical collaboration with Genentech, a member of the Roche Group. As part of the collaboration, the two companies will evaluate the combination of Syndax's...

Read more

AbbVie's Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis

Posted 2 weeks ago in Clinical Trials

NORTH CHICAGO, Ill., Jan. 8, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic...

Read more

Shire Receives FDA Breakthrough Therapy Designation for Maribavir, an Investigational Treatment for Cytomegalovirus (CMV) Infection in Transplant Patients

Posted 2 weeks ago in Clinical Trials

Cambridge, Mass. – January 4, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for maribavir (SHP620), a Phase 3 investigational treatment for cytomegalovirus (CMV) infection and disease in transplant patients resistant or refractory to prior therapy. By targeting a...

Read more

Cantex Pharmaceuticals, Inc. Announces FDA Orphan Drug Designation Has Been Granted to CX-01 for Treatment of Acute Myeloid Leukemia

Posted 2 weeks ago in Clinical Trials

WESTON, Fla., January 3, 2018 -- Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals that improve the treatment of cancers and other life-threatening disorders, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to CX-01 for the treatment of acute myeloid leukemia (“AML”). CX-01 is an investigational agent...

Read more